筆記目錄
處理 UDI 時遇到兩個問題：什麼是「Direct Marking」？我們的醫材須要「Direct Marking」嗎？
所以快速看了〈Unique Device Identification: Direct Marking of Devices〉這份指引，以下節錄重點。
什麼是「Direct Marking」？
「Direct marking, for purposes of UDI requirements, is affixing a UDI permanently on the device itself.」只要把 UDI 永久地標示在器材上，就是「Direct Marking」。
哪類醫材須要「Direct Marking」？
Under 21 CFR 801.45(a), if a UDI is required on a device label, that device is also required to have a UDI permanently affixed to the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. This requirement applies to all device classes, except class I devices that bear a Universal Product Code (UPC) on their label and device packages, as provided in 21 CFR 801.40(d).
Section III.A.2 Which devices are required to be directly marked?
For the purposes of the UDI direct marking requirements, under 21 CFR 801.45, “intended to be used more than once” means intended for repeated uses on or by different patients, e.g., where a device is cleared or approved and labeled for repeated uses on or by different patients. If the device is intended to be used more than once on or by the same patient, and not on or by multiple patients, then the device does not need to be directly marked with a UDI.
Section III.C.1 How is “intended to be used more than once” defined for purposes of UDI direct marking?
綜合以上描述，符合以下三項條件的醫材都須要符合 UDI「Direct Marking」的要求：
- 所有等級，且
- 被要求標籤上須有 UDI，且
- 重複使用，且
- 每次使用前須要再處理 (reprocess)
上述的「重複使用」指的是，被不同病患使用，或用於不同病患。若可使用多次，但都用於同一病患，或被同一病患使用，則不屬於「重複使用」的定義，就不須符合 UDI「Direct Marking」的要求。
但第一等級，且有 Universal Product Code (UPC) 在標籤及包裝上的醫材，可以不用符合。
怎樣才算「Reprocess」？
For purposes of UDI direct marking requirements, we consider a device intended to be reprocessed if it is intended to undergo high-level disinfection and/or sterilization before each use or between uses. This means that devices that are only intended to be cleaned and/or to undergo lower levels of disinfection without subsequent high-level disinfection or sterilization before each use or between uses are not required to be directly marked with a UDI under 21 CFR 801.45.
Section III.C.2 What does FDA consider “intended to be reprocessed” for the purposes of UDI direct marking?
For purposes of this guidance document, high-level disinfection is a lethal process utilizing a sterilant under less than sterilizing conditions. The process kills all forms of microbial life except for large numbers of bacterial spores.
No.4 Footnote
根據上面兩段描述，非滅菌醫材應該都不須要符合「Direct Marking」的要求。
醫材雖不用「Direct Marking」，但廠商自己想要符合「Direct Marking」，這樣可以嗎？可以的。FDA 在這篇指引中鼓勵廠商把 UDI 永久地附於醫材上，就算醫材不須符合「Direct Marking」的要求。
FDA 有規定「Direct Marking」的方法嗎？
沒有。
畢竟醫材類型五花八門，再處理方式也很多元，科技也一直進步，所以 FDA 沒規定「Direct Marking」的方法。只要廠商考慮醫材臨床使用方式，以及在處理方式後，選擇可讓 UDI 整個生命週期間都附在器材上的方法即可。例如，貼上永久性標籤，或直接在雷射雕刻到醫材上，這都符合要求。
